Improvement of laboratory markers of anaemia in the treatment of heavy menstrual bleeding with a 19.5-mg intrauterine device: a pilot study.

OBJECTIVES: To evaluate improvements in laboratory markers of anaemia (haemoglobin, haematocrit, serum iron, and ferritin) in women with subjective heavy menstrual bleeding (HMB) treated with the levonorgestrel 19.5-mg intrauterine device. MATERIALS AND METHODS: We conducted a pilot study at the Department of Obstetrics and Gynaecology, University of Campinas, Faculty of Medical Sciences, Campinas, SP, Brazil. We compared anaemia markers in 73 women aged 18-48 years suffering from HMB, one year after placement of the IUD. RESULTS: The mean age of participants was 30.0 years (range 24-38); more than half were white, and the mean body mass index (kg/m2) was 27.0. Twenty (27.4%) participants exited the study due to loss to follow-up (n = 12; 16.4%), expulsion (n = 7; 9.6%) and uterine perforation (n = 1; 1.4%). One-year post-IUD placement, amenorrhoea was reported by 10 (13.7%) women. According to intention-to-treat and per protocol analyses, the proportion of women with normal haemoglobin levels significantly improved (p = 0.014 in both analyses), as did haematocrit (p < 0.001 in both analyses) and serum iron (p = 0.003 in both analyses) compared to baseline evaluations. The proportion of women with normal ferritin levels also improved (p < 0.001) in both analyses using a cut-off of 15 ng/ml, though no significant difference was observed using a 30 ng/ml cut-off (p = 0.083 in both analyses). CONCLUSION: The levonorgestrel 19.5-mg IUD effectively improved laboratory markers of anaemia one year after placement in women with HMB.

Our results show that the levonorgestrel 19.5-mg IUD significantly improved anaemia markers in subjects with subjective HMB one year after insertion. The occurrence of expulsions emerged as a notable concern in this treatment group.

Pain relief during intrauterine device placement in nulligravid women with both oral ketorolac and an analgesic: a double-blinded randomised trial.

OBJECTIVE: We assessed whether the administration of oral ketorolac with an analgesic provides effective pain relief during placement of an intrauterine device (IUD) in nulligravid women. METHODS: We conducted a double-blinded randomised trial in the Department of Obstetrics and Gynaecology, University of Campinas Faculty of Medical Sciences, Campinas, SP, Brazil. We randomised participants who voluntarily agreed to participate to receive either one pill containing ketorolac 20 mg together with one pill containing dipyrone 300 mg, scopolamine 6.5 µg, hyoscyamine 104 µg, and homatropine 1 mg or placebo 60 min before IUD placement. The participants and providers were blinded to the randomisation group. The primary outcome was pain assessment (measured on a 0-10 visual analogue scale) during IUD placement. RESULTS: We enrolled participants and randomised them 1:1 between November 7, 2023, and January 31, 2024. We analysed 60 women in each group. There were no differences between the groups in the pain score during tenaculum placement, uterine sounding, and IUD placement, and in the overall perception of pain. However, the pain score was significantly lower 10 min after the procedure in women who received the treatment compared with women who received the placebo. CONCLUSION: Oral ketorolac associated with an analgesic administered 60 min before IUD placement was not significantly better than placebo during tenaculum placement, uterine sounding, and IUD insertion, and did not significantly reduce the overall pain perception. However, this treatment did significantly reduce pain 10 min after the procedure. TRIAL REGISTRATION: The trial was registered at Registro Brasileiro de Ensaios Clínicos (REBEC; in English: The Brazilian Registry of Clinical Trials) under number RBR-7phn8yv on November 6, 2023. https://ensaiosclinicos.gov.br/rg/RBR-7phn8yv.

Pain at IUD placement after one pill containing ketorolac 20 mg together with one analgesic pill given 60 min before placement were similar than placebo.

Perspectives of health care providers regarding the levonorgestrel-releasing intrauterine system.

OBJECTIVES: The aims of the study were to assess the number of insertions per month of the 52 mg levonorgestrel-releasing intrauterine system (LNG-IUS) and gauge the knowledge and opinions of health care providers with regard to some of its characteristics and the reasons why women liked using the method. METHODS: An online questionnaire survey was conducted between January and July 2021 at the University of Campinas, Brazil. The survey comprised physicians and nurses from centres that had requested and received donated devices. RESULTS: A total of 65 health care providers answered the questionnaire (41 physicians and 24 nurses). The main misconceptions were related to insertion after an ectopic pregnancy: 60/65 (92.3%) answered that users with previous ectopic pregnancy must have frequent follow-up. Wrong answers were also given on the occurrence of acne (37/65, 56.9%) and depression (32/65, 49.2%). Participants reported that the LNG-IUS was highly effective (100%), long-acting (93.9%) and an appropriate method for controlling uterine bleeding (90.8%) and that it had few side effects (86.2%). CONCLUSION: Our study suggests that health care providers from centres that requested and received LNG-IUS donations, even though they reported adequate knowledge about the device, still had misconceptions with regard to its clinical management.

Association between COVID-19 and vaccination on menstrual cycle.

OBJECTIVE: To evaluate changes in the menstrual pattern of women of reproductive age infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or vaccinated against coronavirus disease 2019 (COVID-19). METHODS: A cross-sectional study at the University of Campinas, Brazil using Google questionnaire applied from December 2021 through February 2022, disseminated through snowball technique. Participants responded about characteristics of their menstrual cycle before the pandemic and before COVID-19 vaccination, and then about characteristics of their cycle 3 months after infection with SARS-CoV-2 and 3 months after vaccination. Our primary outcome was a binary indicator of changes in the menstrual cycle. We used multivariate regression analysis to identify factors associated with menstrual changes. RESULTS: We received 1012 completed questionnaires and 735 (72.7%) were from women aged between 20 and 39 years, 745 (73.6%) were White and 491 (48.6%) lived with a partner. A total of 419 (41.6%) of the women reported SARS-CoV-2 infection; however, only two of them were hospitalized, and 995 (98.8%) of women had at least one dose of COVID-19 vaccine. About menstrual characteristics, 170 (41.3%) reported changes after having COVID-19 and 294 (29.9%) after COVID-19 vaccination, respectively. Few years of schooling, lower income, and non-white ethnicity were related to higher reports of menstrual changes after COVID-19. Menstrual changes after COVID-19 vaccination were associated with not using contraception. Higher body mass index was associated with irregularities in cyclicity and bleeding days, after COVID-19 and COVID-19 vaccination, respectively. CONCLUSION: Our results corroborated the stability of the menstrual cycle after having COVID-19 or COVID-19 vaccination; however, there is a potential relationship between menstrual changes and socioeconomic factors as well as contraceptive use.

Effectiveness and continuation rates of the etonogestrel-subdermal contraceptive implant versus short-acting contraceptive methods offered at no cost in Campinas, Brazil.

OBJECTIVES: To compare the efficacy, reasons for discontinuation and continuation rates of the etonogestrel (ENG)-subdermal contraceptive implant when offered at no cost, and the basis of free choice versus short-acting reversible contraceptive (SARC) methods including combined oral contraceptives (COCs), once-a-month injectables, vaginal ring, and patch. METHODS: We conducted a prospective study at the University of Campinas, Brazil, involving women aged 18 to 40 years. They were counseled on various contraceptive methods before entering the study and followed up every 3 months for up to 24 months. Satisfaction was assessed using a Likert scale. Survival rates were estimated using the Kaplan-Meier test, and curve comparisons were performed using the log-rank test. RESULTS: We enrolled 609 women including 358/609 women (58.8%) who chose the ENG-implant and 251/609 (41.2%) who chose SARC methods. Contraceptive failure and all other reasons for discontinuation were significantly higher in SARC users compared to the ENG-implant users (P < 0.001 and P = 0.002, respectively). The continuation rate was higher among ENG-implant users (89.9% and 75.4%) compared to SARC methods users (27.2% and 15.9%) up to 1 and 2 years after study initiation, respectively. Satisfaction was high in both groups (>82%). CONCLUSIONS: The ENG-implant showed higher contraceptive effectiveness and higher continuation rates than SARC methods up to 2 years after study initiation. Furthermore, users from both groups were highly satisfied with their contraceptive. The main reason for discontinuing use of the ENG-implant was bothersome uterine bleeding, while for SARC methods it was for personal reasons.

A particular epidemiological profile: disparities in access to contraceptive methods in Brazil during the SARS-CoV-2 (COVID-19) pandemic.

Our objective was to study disparities in access to contraception during the COVID-19 pandemic. We performed a cross-sectional study at the University of Campinas, Brazil using a Google questionnaire applied from December 2021 until February 2022, disseminated via snowball technique. The survey asked about sociodemographic characteristics and contraceptive use, as well as the demand for new methods and difficulties in continuing to use contraceptives during the COVID-19 pandemic. We analyzed 1018 completed questionnaires; in total, 742 (72.9%) were women aged between 20 and 39 years, 746 (73.3%) were White and 602 (59.2%) used contraceptives. During the COVID-19 pandemic, about 23% of respondents changed their method and approximately 20% of respondents looked for new methods. Among the latter, 31.3% reported some difficulty with obtaining guidance on new methods while only 5.3% of the respondents reported some difficulty with continuing their contraceptive. The main difficulty in both cases was the difficulty with getting a healthcare provider appointment. Our results point to a particular epidemiological population, of younger black and biracial women, with lower education and lower income, which suffered health disparities during the COVID-19 pandemic and found difficulties with using contraceptives and accessing family planning services.

Uptake, discontinuation, and continuation rate of long-acting contraceptive methods when offered at no cost in Campinas, Brazil.

OBJECTIVES: This study aimed to compare the uptake, reasons for discontinuation, continuation, and satisfaction of long-acting contraceptive methods (LARC) when offered at no cost in Campinas, Brazil. STUDY DESIGN: This was a prospective cohort study conducted at University of Campinas, Campinas, São Paulo, Brazil, including women aged 18 to 48 years, who adopted one of three methods. Participants underwent telephone follow-up every 3 months for up to 24 months after insertion. Satisfaction was assessed at the end of 2 years of use through the Likert scale. RESULTS: We invited 1222 women, and among the 971 women who volunteered to participate in follow-up, 414 (42.6%) chose the levonorgestrel 52-mg intrauterine device (IUD), 358 (36.9%) chose the etonogestrel (ENG) implant, and 199 (20.5%) chose the TCu380A IUD. Discontinuation due to bothersome bleeding was higher among users of the ENG implant (10/358; 2.4%) and the TCu380A IUD (32/199; 8.9%), and expulsion was higher for the TCu380A IUD (30/199; 15.1%). Women continued at 24 months were 340/414 (82.1%), 270/358 (75.4%), and 119/199 (59.8%) among users of the levonorgestrel 52-mg IUD, ENG implant, and TCu380A IUD, respectively. The users of the levonorgestrel 52-mg IUD (301/339, 88.8%), the ENG-implant (222/270, 82.2%), and the TCu380A IUD (105/119, 88.2%) were satisfied or very satisfied by 24 months of follow-up. CONCLUSIONS: The three LARC methods had great uptake, high continuation, and discontinuation due to bothersome bleeding was higher among users of the ENG implant and the TCu380A IUD, and expulsion was higher for the TCu380A IUD compared to the 52-mg levonorgestrel IUD. Most of the participants reported being very satisfied. IMPLICATIONS: When the LARC methods were offered at no cost in a Brazilian public clinic the uptake, satisfaction and continuation were high by 24 months after device placement, and high level of satisfaction was reported by most of the participants.

Clinical Assessment of 3 Intrauterine Devices in Adolescent Girls: A Randomized Clinical Trial.

STUDY OBJECTIVE: To assess clinical performance, bleeding pattern, dysmenorrhea, and satisfaction up to 1 year after placement of 3 types of intrauterine devices (IUDs) (TCu380A, levonorgestrel 52 mg, and levonorgestrel 19.5 mg) in adolescents METHODS: The study was a randomized trial with 318 adolescents allocated to the 3 IUDs. We assessed reasons for removal, continuation, menstrual patterns, dysmenorrhea, and satisfaction. RESULTS: Participants aged (mean ± SD) 17.9 ± 1.4 years, with 80.8% being nulligravidae. After 1 year, 265 (83.3%) continued using the IUD; however, the continuation rate of TCu380A (75.4 ± 4.2) was lower than that of both the levonorgestrel 52-mg (88.6 ± 3.1) and 19.5-mg IUDs (86.8 ± 3.3), and bleeding/pain and expulsion were the main reasons for removal of the TCu380A IUD. The duration of menstruation was longer among the TCu380A IUD users (6.0 ± 2.0 days) than those using the levonorgestrel 52 mg (2.5 ± 3.9) and 19.5 mg (3.2 ± 3.2) devices, P < .001. Amenorrhea was reported by 49.5% and 37.8% users of the levonorgestrel 52-mg and 19.5-mg devices, respectively, P < .001. Dysmenorrhea was reported in 68.5% of all participants at the baseline; this was 67.9% of the TCu380A group and 33.3% and 36.0% of the levonorgestrel 52-mg and 19.5-mg IUD groups, respectively, P < .001. Satisfaction ranged from 80.7% in the TCu380A group to 97.8% in the levonorgestrel 52-mg group (P = .03). CONCLUSION: The 3 IUDs are suitable for adolescents, with high contraceptive efficacies and rates of continuation within 1 year of use and high degrees of satisfaction. Users of the hormonal IUDs reported lower expulsion rates, more favorable menstrual patterns, and less dysmenorrhea compared with the TCu380A IUD.

Pain and ease of insertion of three different intrauterine devices in Brazilian adolescents: A participant-blinded randomized trial.

OBJECTIVES: To compare pain and ease of insertion of the copper 380 mm2, levonorgestrel 52 mg, and levonorgestrel 19.5-mg intrauterine devices (IUDs) in Brazilian adolescents. STUDY DESIGN: We conducted a participant-blinded randomized trial at two clinics in Brazil. We enrolled 318 adolescents<19 years old in a 1:1:1 ratio from November 2021 to February 2022. We informed the adolescents about the IUD type inserted after they evaluated the pain associated with the IUD insertion using a Visual Analogue Scale and immediately after that the healthcare provider who placed the IUD evaluated the ease of the procedure. RESULTS: The VAS pain level was significantly higher after the levonorgestrel 52-mg IUD placement, median and [interquartile range, IQ] 8.0 [4.0] than the copper 380-mm2 IUD 7.0 [4.0], and the levonorgestrel 19.5-mg IUD 7.0 [6.0] (p = 0.001). The placement was easier after the copper 380-mm2 IUD (87/106, 82.1%) and the levonorgestrel 19.5-mg IUD (91/106, 85.8%) when compared with the levonorgestrel 52-mg IUD (75/105, 70.7%). After multiple logistic regression analyses, the higher VAS pain scores were associated with the levonorgestrel 52-mg IUD (OR = 2.90), low number of pregnancies (OR -0.48), and with a history of dysmenorrhea (OR = 2.67). CONCLUSIONS: The placement of the copper 380-mm2 IUD and the levonorgestrel 19.5-mg IUD was associated with lower pain according to the adolescent and was easier according to the provider when compared with the levonorgestrel 52-mg IUD. However, the small observed differences may not be clinically relevant. IMPLICATIONS: We found that the three types of IUDs were generally easy to place; however, mean pain scores were high during insertions. Our findings of high pain scores reinforce the need for interventions to reduce pain for adolescent IUD insertion.